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© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
Updates in Miscarriage Management
Jen Kaiser, MD, MA, MSCI
Assistant Professor
Family Planning
9/20/2019
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• Review of miscarriage management
• Medical management
– Mifepristone
– Regimen and follow up
• Implementation
– Logistics
– Support
Outline
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Take Home Points
• Mifepristone is safe!
• Improves miscarriage management
• Effort needed to implement
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Miscarriage or Early Pregnancy Loss
• Common
– ~15% of clinically recognized pregnancies
• Prior to 12 weeks 6 days
– Embryonic demise
– Anembryonic gestation
F i n e r a n d
Z o l n a .
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Management Options
• Expectant management
• Medical management
• Surgical management
– D&C
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• Misoprostol
• Change in recommended regimen
• Mifepristone + Misoprostol
• ACOG supported
ACOG, Practice Bulletin No. 67
Medical Management
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What is Mifepristone?
• RU-486 or Mifeprex
• Anti-glucocorticoid
– Potent anti-progestin
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Mechanism of Action: Pregnancy
Binds progesterone receptor
Alters endometrium
Trophoblast separation Prostaglandin release
βHCG
Bleeding
Contractility &cervical ripening
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Variety of Mifepristone Uses
1. Cushing’s Syndrome (Korlym)
2. Fibroids
3. Endometriosis
4. Emergency Contraception
5. Term cervical ripening
6. Medical abortion
Sartor et al, 1996; Kettel et al, 1998; Steinauer et al, 2004; von Hetzen et al, 2002; Wing et al, 2000
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Use in Miscarriage Management
• Mifepristone
– Progesterone blocker
• Misoprostol
– Prostaglandin analogue
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Mechanism of Action
Misoprostol: RhythmicUterine
Contractions
Mifepristone: Progesterone
Blockade
DecidualNecrosis
CervicalRipening
Detachment Expulsion
Abortion
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Miscarriage Management
Schreiber et al, NEJM, 2018
300 women
Anembryonic or fetal demise <12w
149 women:
200mg mife+800mcg miso
151 women:
800mcg miso
Repeat miso or D&C
Follow up 24-72
hours later
Primary Outcome: expulsion of gestational sac 1-3 days post-miso by TVUS
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Success Rates
Schreiber et al, NEJM, 2018
NNT = 6.8
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Gestational Age Limitations
Schreiber et al, NEJM, 2018
No. participants
(%)Treatment Success
Mifepristone Misoprostol
10-12 wk 18 (6) 70.0% 75.0%
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Regimen
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Patient Selection
• Medical history
• 10 weeks or less gestation*
– Based on SIZE
*Exceptions can be made up to 12 weeks
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Contraindications to Medical Management
• Anemia (Hgb <9)
• Chronic adrenal failure
• Porphyrias
• Ectopic pregnancy
• Long-term corticosteroid therapy
• Anticoagulation therapy
• IUD in place (take it out)
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Patient Selection and Intake
• Pregnancy dating
– LMP
– Ultrasound
– Pelvic exam
• Contraceptive plan
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• Provide Patient Medication Guide
• Sign Patient Agreement Form
• Print all materials online:
• Explain wording on form
https://www.earlyoptionpill.com/
for-health-professionals/patient-support-materials/
First!
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Regimen
1. Give 200mg mifepristone PO in clinic
2. Patient waits 24-48 hours
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At Home – 24-48 hours later
1. Take phenergan and ibuprofen
1. Place 800 mcg misoprostol
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Pain Management
• Ibuprofen
– 800mg q8hrs
• Norco or Percocet
– 5/325, 1 tab q6hrs prn
– No evidence to support its routine prescription
• Supportive measures
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Patient Counseling
• Cramping
– Starts 30-60 minutes after misoprostol
• Bleeding
– Can be heavy, clots to lemon size
• Worst point: 4 hours after taking tablets
(average)
• Bleeding for 1-2 weeks (light)
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Follow up
• Phone call in 3 to 5 days
• Day 3 to 14 follow up ultrasound
• Day 3 to 14 serum HCG
– Requires HCG draw on day of mifepristone
– F/u draw can be done at any lab
– Decrease by >50% from Day 1
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Contraception
• Pills, patch, ring, depo: start within 5 days
• Nexplanon: place at time of mifepristone
• IUD: place at follow up
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Side Effects
• Misoprostol related
– Fever
– Chills
– Nausea/vomiting
– Diarrhea
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Mifepristone FDA Black Box Warning
• Added in 2004
– Atypical bacterial infections
– Bleeding
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Bacterial Infection
• Clostridium sordelli
– 9 deaths (2000 to 2012)
– Vaginal misoprostol
• General infection rate
– 0.01-0.5%
Dempsey, Clin Obstet Gyn, 2012; Fischer et al, NEJM, 2005; Meites et al, NEJM, 2010; Chen and Creinin,
Obstet Gynecol, 2015
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Bleeding
• Prolonged heavy bleeding
– After medical abortion
– 0.03-0.6% require blood
transfusion
– 0.049% require D&C
Chen and Creinin, Obstet Gynecol, 2015; Hausknecht, Contraception, 2003
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Implementation
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REMS
• Risk Evaluation and Mitigation Strategy
– Drugs with serious safety concerns
– Ensures benefits outweigh risks
– Different for different drugs
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Mifepristone REMS
• Registered ordering provider
• Mifeprex Patient Medication Guide
• Mifeprex Patient Agreement Form
• Dispensed in clinic, medical office, hospital
• Taken in presence of provider
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www.earlyoptionpill.com/for-health-professionals
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Implementation success
• University of Utah wide
• Protocol creation
• Teamed with pharmacy
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We are here to help!
• Family Planning Division
– David Turok, MD
– Lori Gawron, MD
– Jen Kaiser, MD
– Jessica Lewis-Caporal, NP
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Take Home Points
• Mifepristone is safe!
• Improves miscarriage management
• Effort needed to implement
© U N I V E R S I T Y O F U T A H H E A L T H , 2 0 1 7
Questions?
Thank you!
